# K162851: eLyx-PRO

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Sensory Concept SA
- Decided: Jan 24, 2017 after 105 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043329: Omnilux Revive and Blue, Photo Therapeutics Limited (2005) Summary page 4.
- K050216: Omnilux Revive and Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 4.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 4.

## Indications for use
eLyx PRO is intended to emit in the blue and red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for the temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness

Source page: https://510kreport.com/device/K162851
Methodology: https://510kreport.com/methodology